Malaysia is a developing country located in Southeast Asia with a national
centre for Pharmacovigilance, namely the ‘National Adverse Drug Reaction
Monitoring Centre’ that services the entire country. Some major hospitals
and pharmaceutical companies also operate ADR monitoring systems, but the
national centre consolidates all of their reports. Normally, reports from
doctors, pharmacist and dentists are completed on a voluntary basis, but
reports from marketing authorization holders are mandatory. These
personnel monitor drugs for human use, vaccines, biological and herbal
remedies. 12 The National Drug Reaction (ADR) centre uses prepaid postage
report forms or report cards that are updated every month. The national
centre has an advisory committee that assesses the casualties reported in
the ADRs. The Malaysian Adverse Drug Reaction Advisory Committee (MADRAC)
was established under the Drug Control Authority (DCA) to monitor the
safety profiles of drugs registered for use in Malaysia. MADRAC provides
the DCA with information regarding drug safety both locally and
internationally. The National Drug Safety Monitoring Centre, which is the
secretariat to MADRAC, was accepted as the 30th member of the World Health
Organization (WHO) Safety Monitoring Program in 1990. Under the monitoring
programme, all ADR reports that are received and screened by MADRAC are
submitted to the Uppsala Monitoring Centre in Sweden for inclusion into
the WHO database.
MADRAC also promotes ADR reporting in Malaysia, provides information
and advises the DCA such that regulatory action can be taken based on ADRs
that are received both locally and internationally. It also provides
information to doctors, pharmacists and other health care professionals
regarding ADRs and participates in the WHO ADR monitoring programm.
Limitations of the current drug safety system in Malaysia
Even though the Malaysian system and programme have been established more
than 20 years, it still has few drawbacks.. The major weaknesses of the
drug safety system in Malaysia are as follows:-
1. Lack of awareness about drug safety among health professionals
regarding pharmacovigilance.4
2. Lack of awareness about the existence, function and purpose of national
ADR reporting.4
3. Difficulty of signal generation due to the lack of a national
computerized database on the drug prescribed.5
4. Inability to involve pharmaceutical industries in drug safety issues.4
5. Lack of information on genetic effect, social practices and drug
interaction and indication contra associated with drugs.4
6. Presence of only a few reports on traditional and herbal drugs, which
are widely used.4
7. under reporting – major weakness of all spontaneous reporting
systems.7
8. No involvement of nursing staff and consumers in the ADR monitoring
program.6
9. Limited role of NGOs in drug safety issues.
10. Limited role of mass media in public drug safety education.
11. Selective reporting among healthcare professionals (reporting bias).
12. Poor at detecting delayed ADRs.
Ideas on how to improve the drug safety system in Malaysia
A. Strategies to improve the drug safety system 9 in Malaysia:
1. Enhancing, strengthening and empowering the role of the MADRAC.
There is an urgent need to increase the ability of MADRAC to regulate
drugs after they reach the market and to conduct long-term post marketing
studies for all drugs available in the Malaysian market.
MADRAC also needs to develop active new pharmacoepidemiological methods
and tools, train new staff and increase their resources and funds to
improve its role in the lives of healthcare professionals and public.
2. Starting awareness programs for healthcare professionals to explain the
importance, function and purposes of the national drug safety monitoring
program in Malaysia. MADRAC should increase the role of health care
professionals in this program and in particular, include nurses, community
pharmacists and private general practitioners in the reporting of ADRs.
This can result in increased knowledge about the harmful effects of drugs
currently used in the country.
3. Development of a consumer reporting program, 8 which would be
beneficial to the existing program available in Malaysia and increase the
information and knowledge regarding ADRs. This will allow MADRAC to
overcome the main problem of under reporting while improving consumer
rights, which will eventually improve the quality of life and patient
safety in Malaysia.
4. Strengthening the role of pharmacovigilance by developing new
methods for risk analysis and risk management. This will strengthen the
methods for safety surveillance and allow enhanced detection,
understanding, prediction and prevention of ADRs.
5. Improving communication and information flow between healthcare
professionals and the public.
6. Involvement of Non-Governmental Organizations (NGOs) in drug
safety issues to utilise the important role of NGOs at the local level. In
addition, NGO such as Consumer Association of Penang (CAP) and Federation
of Malaysian Consumers Associations (FOMCA) have extensive experience in
dealing with public interests. They can understand public needs and
choices, as well as advocate for the rights of the people.
7. The full involvement of drug industries in drug safety issues in
Malaysia. There are 76 licensed local manufactures and 136 licensed local
manufacturers of traditional medicine. One hundred seventy two companies
are involved in the development and production of medicine and traditional
medicine. However, the Pharmaceutical industry in Malaysia has little
regard for safety monitoring. The full involvement of drug industry as key
player in drug safety can improve pharmacovigilance in Malaysia. The
companies should regularly report the ADRs associated with their products
to the national center.
8. Inclusion of providers of local and herbal medicine into the drug
safety program in Malaysia. The national drug safety system should monitor
and evaluates ADRs associated with herbal medicine. This is very rare, but
in rapidly developing countries, there are local officials that offer
these activities. There is a lack of methodological uniformity for
identification and measurement of herbal medicines, which is widely in
Malaysia. Moreover, there are very few ADR reports about these compounds
in Malaysia.
9. Increase the role of the mass media in public drug safety
education. The media will remain a key provider of drug information and a
key player in drug safety issues. It can also play an important role in
educating the public about the harmful effects of drug and strengthening
consumers’ views about medicines by having a weekly column and inviting
healthcare professionals to contribute.
10. Teaching pharmacovigilance. Pharmacovigilance should be taught to
undergraduate students of Medicine, Nursing, Pharmacy and other healthcare
related studies. Thus, these students will be aware of the program when
they start their practices. Pharmacovigilance modules must be linked to
courses on the rational use of medicines (RUM). The Uppsala Monitoring
Centre (UMC), the international collaboration centre for ADR monitoring,
has suggested a number of basic components of a pharmacovigilance course
for pharmacologists and other healthcare personnel. Currently in Malaysia,
education programs for Pharmacovigilance for undergraduate students are
lacking. For example, in the School of Pharmaceutical Sciences at
Universiti Sains Malaysia, Penang, students are given less than two hours
of instruction regarding pharmacovigilance during their four-year Bachelor
of Pharmacy course.
3. Annual report of Malaysian Adverse Drug Reactions Advisory
Committee, 2007. Available at http://www.bpfk.gov.my
4. Hag ASM. Pharmacovigilance initiatives in Malaysia. Drug
Information Journal 2003; 57: 143- 8.
5. Olsson S. National pharmacovigilance systems, 2-edition,
Uppsala Monitoring centre, 1999.
6. Palaian S, Alshakka M, Mohamed Izham. Developing a consumer
reporting program in Malaysia: a novel initiative to improve
pharmacovigilance. Pharm World Sci 2010; 32(1):2-6.
7. Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug
reactions: predictors of under-reporting in Malaysia. Pharmacoepidemiol
Drug Saf 2007; 16(2):223-8.
8. Blenkinsopp A, Wilkie P, Wang M, Routledge PA. Patient reporting
of suspected adverse drug reactions: a review of published literature and
international experience. Br J Clin Pharmacol 2006; 63(2):148-156.
9. The Future of Drug Safety – Promoting and Protecting the Health of
the Public. FDA’s Response to the Institute of medicine’s Report, 2006.
Rapid Response:
How Can Malaysia Improve its Drug Safety System?
Dear Editor-in-Chief,
Malaysia is a developing country located in Southeast Asia with a national
centre for Pharmacovigilance, namely the ‘National Adverse Drug Reaction
Monitoring Centre’ that services the entire country. Some major hospitals
and pharmaceutical companies also operate ADR monitoring systems, but the
national centre consolidates all of their reports. Normally, reports from
doctors, pharmacist and dentists are completed on a voluntary basis, but
reports from marketing authorization holders are mandatory. These
personnel monitor drugs for human use, vaccines, biological and herbal
remedies. 12 The National Drug Reaction (ADR) centre uses prepaid postage
report forms or report cards that are updated every month. The national
centre has an advisory committee that assesses the casualties reported in
the ADRs. The Malaysian Adverse Drug Reaction Advisory Committee (MADRAC)
was established under the Drug Control Authority (DCA) to monitor the
safety profiles of drugs registered for use in Malaysia. MADRAC provides
the DCA with information regarding drug safety both locally and
internationally. The National Drug Safety Monitoring Centre, which is the
secretariat to MADRAC, was accepted as the 30th member of the World Health
Organization (WHO) Safety Monitoring Program in 1990. Under the monitoring
programme, all ADR reports that are received and screened by MADRAC are
submitted to the Uppsala Monitoring Centre in Sweden for inclusion into
the WHO database.
MADRAC also promotes ADR reporting in Malaysia, provides information
and advises the DCA such that regulatory action can be taken based on ADRs
that are received both locally and internationally. It also provides
information to doctors, pharmacists and other health care professionals
regarding ADRs and participates in the WHO ADR monitoring programm.
Limitations of the current drug safety system in Malaysia
Even though the Malaysian system and programme have been established more
than 20 years, it still has few drawbacks.. The major weaknesses of the
drug safety system in Malaysia are as follows:-
1. Lack of awareness about drug safety among health professionals
regarding pharmacovigilance.4
2. Lack of awareness about the existence, function and purpose of national
ADR reporting.4
3. Difficulty of signal generation due to the lack of a national
computerized database on the drug prescribed.5
4. Inability to involve pharmaceutical industries in drug safety issues.4
5. Lack of information on genetic effect, social practices and drug
interaction and indication contra associated with drugs.4
6. Presence of only a few reports on traditional and herbal drugs, which
are widely used.4
7. under reporting – major weakness of all spontaneous reporting
systems.7
8. No involvement of nursing staff and consumers in the ADR monitoring
program.6
9. Limited role of NGOs in drug safety issues.
10. Limited role of mass media in public drug safety education.
11. Selective reporting among healthcare professionals (reporting bias).
12. Poor at detecting delayed ADRs.
Ideas on how to improve the drug safety system in Malaysia
A. Strategies to improve the drug safety system 9 in Malaysia:
1. Enhancing, strengthening and empowering the role of the MADRAC.
There is an urgent need to increase the ability of MADRAC to regulate
drugs after they reach the market and to conduct long-term post marketing
studies for all drugs available in the Malaysian market.
MADRAC also needs to develop active new pharmacoepidemiological methods
and tools, train new staff and increase their resources and funds to
improve its role in the lives of healthcare professionals and public.
2. Starting awareness programs for healthcare professionals to explain the
importance, function and purposes of the national drug safety monitoring
program in Malaysia. MADRAC should increase the role of health care
professionals in this program and in particular, include nurses, community
pharmacists and private general practitioners in the reporting of ADRs.
This can result in increased knowledge about the harmful effects of drugs
currently used in the country.
3. Development of a consumer reporting program, 8 which would be
beneficial to the existing program available in Malaysia and increase the
information and knowledge regarding ADRs. This will allow MADRAC to
overcome the main problem of under reporting while improving consumer
rights, which will eventually improve the quality of life and patient
safety in Malaysia.
4. Strengthening the role of pharmacovigilance by developing new
methods for risk analysis and risk management. This will strengthen the
methods for safety surveillance and allow enhanced detection,
understanding, prediction and prevention of ADRs.
5. Improving communication and information flow between healthcare
professionals and the public.
6. Involvement of Non-Governmental Organizations (NGOs) in drug
safety issues to utilise the important role of NGOs at the local level. In
addition, NGO such as Consumer Association of Penang (CAP) and Federation
of Malaysian Consumers Associations (FOMCA) have extensive experience in
dealing with public interests. They can understand public needs and
choices, as well as advocate for the rights of the people.
7. The full involvement of drug industries in drug safety issues in
Malaysia. There are 76 licensed local manufactures and 136 licensed local
manufacturers of traditional medicine. One hundred seventy two companies
are involved in the development and production of medicine and traditional
medicine. However, the Pharmaceutical industry in Malaysia has little
regard for safety monitoring. The full involvement of drug industry as key
player in drug safety can improve pharmacovigilance in Malaysia. The
companies should regularly report the ADRs associated with their products
to the national center.
8. Inclusion of providers of local and herbal medicine into the drug
safety program in Malaysia. The national drug safety system should monitor
and evaluates ADRs associated with herbal medicine. This is very rare, but
in rapidly developing countries, there are local officials that offer
these activities. There is a lack of methodological uniformity for
identification and measurement of herbal medicines, which is widely in
Malaysia. Moreover, there are very few ADR reports about these compounds
in Malaysia.
9. Increase the role of the mass media in public drug safety
education. The media will remain a key provider of drug information and a
key player in drug safety issues. It can also play an important role in
educating the public about the harmful effects of drug and strengthening
consumers’ views about medicines by having a weekly column and inviting
healthcare professionals to contribute.
10. Teaching pharmacovigilance. Pharmacovigilance should be taught to
undergraduate students of Medicine, Nursing, Pharmacy and other healthcare
related studies. Thus, these students will be aware of the program when
they start their practices. Pharmacovigilance modules must be linked to
courses on the rational use of medicines (RUM). The Uppsala Monitoring
Centre (UMC), the international collaboration centre for ADR monitoring,
has suggested a number of basic components of a pharmacovigilance course
for pharmacologists and other healthcare personnel. Currently in Malaysia,
education programs for Pharmacovigilance for undergraduate students are
lacking. For example, in the School of Pharmaceutical Sciences at
Universiti Sains Malaysia, Penang, students are given less than two hours
of instruction regarding pharmacovigilance during their four-year Bachelor
of Pharmacy course.
References
1. MADRAC Web site available:
http://www.cornerstonemsc.net/bpfk/index.cfm?menuid=24&parentid=16
2. Drug, device and cosmetic regulation in Malaysia: 2005 Update
Pacific Bridge Medical. Available at
http://www.pacificbridgemedical.com/publications/html/malaysiajuly05.htm
3. Annual report of Malaysian Adverse Drug Reactions Advisory
Committee, 2007. Available at http://www.bpfk.gov.my
4. Hag ASM. Pharmacovigilance initiatives in Malaysia. Drug
Information Journal 2003; 57: 143- 8.
5. Olsson S. National pharmacovigilance systems, 2-edition,
Uppsala Monitoring centre, 1999.
6. Palaian S, Alshakka M, Mohamed Izham. Developing a consumer
reporting program in Malaysia: a novel initiative to improve
pharmacovigilance. Pharm World Sci 2010; 32(1):2-6.
7. Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug
reactions: predictors of under-reporting in Malaysia. Pharmacoepidemiol
Drug Saf 2007; 16(2):223-8.
8. Blenkinsopp A, Wilkie P, Wang M, Routledge PA. Patient reporting
of suspected adverse drug reactions: a review of published literature and
international experience. Br J Clin Pharmacol 2006; 63(2):148-156.
9. The Future of Drug Safety – Promoting and Protecting the Health of
the Public. FDA’s Response to the Institute of medicine’s Report, 2006.
Competing interests:
None declared
Competing interests: No competing interests